Data / Medical devices / General Purpose Reagent / Japan
FDA-registered makers of General Purpose Reagent in Japan: 6 establishments
6 establishments in Japan are registered with the FDA to make General Purpose Reagent (product code PPM). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- General Purpose Reagent
- Product code
- PPM
- Country
- Japan
Makers of General Purpose Reagent in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jeol Ltd. | Musashimurayama Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Ono Factory | Ono Hyogo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yuaikasei Co.,ltd. | Amagasaki Hyogo, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.